Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Takeda
• Treatments: Ciclesonide

Criteria

Main inclusion criteria:

• Written informed consent

• 18 years or older with diagnosis of asthma for at least 6 months

• Clinically stable asthma at the time of study enrollment

• Clinical requirements for treatment with ICS as outlined in the Canadian Asthma Consensus Guidelines

• If patients are currently on ICS, the dose must be stable for 3 months and they must be willing to switch

Main exclusion criteria:

• On combination therapy (ICS + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy

• Severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids

• Mild asthma requiring short acting beta-2-agonists only

• Patients with a contraindication to ICS therapy

• Any other disease or medical condition requiring further clinical evaluation, which in the opinion of the Primary Care Practitioner may interfere with the clinical study or interfere with the diagnosis of asthma.

• Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women